Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.

Not Applicable

• Conditions: Esophageal cancer

• Registration Number: JPRN-UMIN000027589
• Lead Sponsor: The University of Tokyo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-01
• Last Update Posted: 22 January 2024
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2.With active systemic infection disease 3.With active hepatitis B or C 4.With HIV infection 5.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6.Severe psychological illness. 7.With continuous systemic steroid or immune-suppressive drug therapy. 8.Poorly controlled diabetes mellitus or thyroid diseases. 9.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10.With a history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11.Pregnant and/or nursing women or men who wish to have children in future 12.Judged to be unfit to participate in this study by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence free survival(RFS)

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS) Response rate(RR) R0 resction rate pN positive rate Adverse events